MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING; ICP MONITORING CATHETER

Model Number	PSO-VT
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was implanted on june 22,the machine showed e001 on june 29.
Event or Problem Description
The catheter was implanted on (b)(6), the machine showed e001 on (b)(6).
Additional Manufacturer Narrative
Error e001 confirmed on monitor.The micro-cable is broken in the dongle shell, the catheter seems to have worked for several days, implanted on (b)(6) 2023 and explanted on (b)(6).Abnormal excessive traction is undoubtedly the cause of the breakage of the micro cable, especially since no jamming of it is visible at the electronic card; user error confirmed.

• Brand Name: PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17817504
• Report Number: 3001587388-2023-23418
• Device Sequence Number: 12302333
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)221222(17)271101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male